The Evaluation of an Amino Acid- Oral Re-hydration Solution (Enterade®) to Improve Quality of Life in Solid Tumor Cancer Patients by Reduction of Chemotherapy Related Diarrhea

Background: Chemotherapy related diarrhea (CRD) is a common adverse effect of many chemotherapy agents used to treat cancer. CRD negatively affects quality of life (QOL) for cancer patients and often results in treatment delays, hold, dose reductions, and hospitalizations affecting morbidity and mortality. Proper management of CRD with novel therapeutics is needed to improve the quality of life and patient outcomes for this population. Purpose: The purpose of this study was to evaluate the use of a proprietary amino acid-oral rehydration solution (AA-ORS) known as Enterade® to reduce the severity of CRD, to improve patient reported QOL among patients over the age of 18, diagnosed with solid tumors, and receiving systemic chemotherapy, to reduce treatment holds, delays, dose modifications, prevention of weight loss, and subjective improvement of associated gastrointestinal mucositis physical symptoms. Conceptual Model: Imogene M. King’s Theory of Goal Attainment was utilized as the framework for this study. Methodology: A quasi-experimental study without randomization in a single population with two separate measurements over time was performed in a National Cancer Institute (NCI) designated cancer center in the South-Central United States. The variables included sociodemographic data, cancer diagnosis, chemotherapy treatment regimens, Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade of diarrhea, stool consistency using the Bristol Stool Scale, use of antidiarrheals, associated gastrointestinal mucositis symptoms affecting QOL, and QOL measured with the Functional Assessment of Chronic Illness Therapy-Diarrhea survey (FACIT-D). Results: A total of 22 participants enrolled in the study. Sixteen completed both the pre- survey and post survey. A statistically significant difference was not found between the patient’s subjective report of quality of life when comparing pre and post survey responses. There was a statistically significant improvement from baseline in the QOL questions specific to bowel concerns due to diarrhea with a mean pre-survey response score of 35.3 versus a post survey score of 29.2 (p = .003). There was a reduction in the CTCACE grade of diarrhea demonstrating a reduction in the frequency of stools per day (p = .001) and a change in the consistency of stools moving from watery to more formed stools using the Bristol Stool Scale (p =.049). Conclusion: Use of AA-ORS in this study was found to be useful in the reduction of CRD in patients receiving systemic oncology therapies. This study needs to be replicated with a larger, more inclusive sample size to further support the use of AA-ORS in the reduction of CRD and QOL